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Phase 3 Completed N=673 Randomized Treatment

Safety and Efficacy of a Switch to Doravirine, Tenofovir, Lamivudine (MK-1439A) in Human Immunodeficiency Virus (HIV-1)-Infected Participants Virologically Suppressed on an Anti-retroviral Regimen in Combination With Two Nucleoside Reverse Transcriptase Inhibitors (MK-1439A-024)

Source: ClinicalTrials.gov NCT02397096 ↗
Enrolled (actual)
673
Serious AEs
4.4%
Results posted
Apr 2019
Primary outcomePrimary: Percentage of Participants Maintaining Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL — 90.8; 94.6 Percentage of Participants
◆ Published Evidence
Established
94citations · ~13 / year
Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains HIV-1 Virologic Suppression Through 48 Weeks: Results of the DRIVE-SHIFT Trial.
Journal of acquired immune deficiency syndromes (1999) · 2019 · Open access · Likely link

Summary

The multicenter, open label, randomized study will evaluate the safety and efficacy of a switch to MK-1439A (MK-1439 [doravirine] plus lamivudine and tenofovir disoproxil fumarate) in HIV-1-infected participants virologically suppressed on a protocol-specified antiretroviral regimen. The primary hypothesis is that a switch to doravirine, tenofovir, lamivudine will be non-inferior to continuation of the regimen at Screening for 24 weeks, as assessed by the proportion of participants maintaining HIV-1 ribonucleic acid (RNA) <50 copies/mL. The Base Study results will be based on the first 48 weeks of this ongoing study.

Linked Publications (5)

  • Switching to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate (DOR/3TC/TDF) Maintains HIV-1 Virologic Suppression Through 48 Weeks: Results of the DRIVE-SHIFT Trial.
    Journal of acquired immune deficiency syndromes (1999) · 2019 · 94 citations · Open access · Likely link
  • Brief Report: Switching to DOR/3TC/TDF Maintains HIV-1 Virologic Suppression Through Week 144 in the DRIVE-SHIFT Trial.
    Journal of acquired immune deficiency syndromes (1999) · 2021 · 54 citations · Open access · Likely link
  • Population Pharmacokinetic and Pharmacodynamic Analysis To Evaluate a Switch to Doravirine/Lamivudine/Tenofovir Disoproxil Fumarate in People Living with HIV-1.
    Antimicrobial agents and chemotherapy · 2020 · 2 citations · Open access · Likely link
  • Factors Associated With Weight Change After Continuing or Switching to a Doravirine-based Regimen.
    Open forum infectious diseases · 2025 · 1 citation · Open access · Likely link
  • Efficacy and Safety of Doravirine-based Regimens by Sex and Race: Long-term Results From Three Phase 3 Clinical Trials.
    Open Forum Infectious Diseases · 2025 · 0 citations · Open access · Likely link

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants Maintaining Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) <50 Copies/mL
90.8; 94.6
SECONDARY
Mean Change From Baseline in Fasting Low-density Lipoprotein Cholesterol (LDL-C)
108.82; 109.00; -16.54; -1.94 <0.0001 sig
SECONDARY
Mean Change From Baseline in Fasting Non-high-density Lipoprotein Cholesterol (Non-HDL-C)
139.14; 137.99; -24.74; -1.31 <0.0001 sig
SECONDARY
Percentage of Participants Maintaining HIV-1 RNA <50 Copies/mL
93.7; 94.6
SECONDARY
Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
664.5; 655.6; 5.1; 18.0
SECONDARY
Mean Change From Baseline in Cluster of Differentiation (CD4) Cell Counts
664.5; 655.6; 5.1; 18.0
SECONDARY
Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
92.8; 93.3
SECONDARY
Percentage of Participants Maintaining HIV-1 RNA <40 Copies/mL
92.8; 93.3
SECONDARY
Percentage of Participants With HIV-1 RNA >=50 Copies/mL
1.6; 1.8
SECONDARY
Percentage of Participants Experiencing ≥1 Adverse Event (AE)
68.9; 52.5
SECONDARY
Percentage of Participants Experiencing ≥1 Serious Adverse Event (SAE)
2.9; 3.6
SECONDARY
Percentage of Participants Discontinuing From Study Medication Due to an AE(s)
2.5; 0.4

Eligibility Criteria

Inclusion Criteria

Inclusion Criteria include, but are not limited to:

  • Have plasma Human Immunodeficiency Virus-1 Ribonucleic Acid (HIV-1 RNA) levels below the limit of quantification (BLoQ) ( = 6 months.
  • Receiving first or second retroviral regimen (participants receiving a NNRTI at Screening must be on their first retroviral regimen)
  • No history of using an experimental NNRTI
  • Has a genotype prior to starting his/her initial antiretroviral regimen and no known resistance to any of the study agents
  • Not receiving lipid lowering therapy or on a stable dose of lipid lowering therapy at the time of enrollment
  • Has the following laboratory values at screening within 30 days prior to the treatment phase of this study: Alkaline phosphatase ≤ 3.0 x upper limit of normal (ULN), Serum aspartate aminotransferase (AST) and serum alanine aminotransferase (ALT) ≤ 5.0 x ULN, and Hemoglobin ≥9.0 g/dL (if female) or ≥10.0 g/dL (if male)
  • Has a calculated creatinine clearance at the time of screening ≥ 50 mL/min, based on the Cockcroft-Gault equation
  • Male or female participant not of reproductive potential or, if of reproductive potential, agrees to avoid becoming pregnant or impregnating a partner while receiving study drug and for 14 days after the last dose of study drug by complying with one of the following: 1) practice abstinence from heterosexual activity, or 2) use acceptable contraception during heterosexual activity
  • For inclusion in Study Extension 1 (optional): completed the Week 48 visit; considered to have derived benefit from study participation up to Week 48; considered to be a clinically appropriate candidate for an additional 2 years treatment with study drug
  • For inclusion in Study Extension 2 (optional): completed the Week 144 visit; considered to have derived benefit from study participation up to Week 144; considered to be a clinically appropriate candidate for an additional 2 years treatment with study drug
  • For inclusion in Study Extension 3 (optional): completed the Week 240 visit; considered to have derived benefit from study participation up to Week 240; considered to be a clinically appropriate candidate for an additional 2 years treatment with study drug

Exclusion Criteria

Exclusion Criteria include, but are not limited to:

  • Uses recreational or illicit drugs or has a recent history of drug or alcohol abuse or dependence
  • Received treatment for a viral infection other than HIV-1, such as hepatitis B, with an agent that is active against HIV-1 such as adefovir, emtricitabine, lamivudine, or tenofovir
  • Has documented or known resistance to study drugs including doravirine, lamivudine, and/or tenofovir
  • Participated in a study with an investigational compound or device within 30 days or anticipates doing so during the course of this study
  • Used systemic immunosuppressive therapy or immune modulators within 30 days or anticipates needing them during the course of this study (short courses of corticosteroids will be allowed)
  • Current, active diagnosis of acute hepatitis due to any cause (participants with chronic hepatitis B and C may enter the study as long as they fulfill all entry criteria, have stable liver function tests, and have no significant impairment of hepatic function)
  • Has evidence of decompensated liver disease or has liver cirrhosis and a Child-Pugh Class C score or Pugh-Turcotte score >9
  • Pregnant, breastfeeding, or expecting to conceive at any time during the study
  • Female and is expecting to donate eggs or male and is expecting to donate sperm during the study
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02397096) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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